Hypoxic-Ischemic Encephalopathy Clinical Trial
Official title:
Effect of Non-nutritive Sucking Stimulation on Oral Intake and Early Feeding Skills in Newborns With Perinatal Asphyxia: A Randomized Controlled Trial
Verified date | October 2023 |
Source | Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated. Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding. The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly. The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 25, 2023 |
Est. primary completion date | May 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 34 Months to 41 Months |
Eligibility | Inclusion Criteria: - to be diagnosed with asphyxia, - to have received hypothermia treatment, - to have started enteral nutrition, - to have physiological stability to tolerate NNS stimulation. Exclusion Criteria: - Having a craniofacial anomaly, - having a congenital anomaly, - being referred to another center/hospital during treatment. |
Country | Name | City | State |
---|---|---|---|
Turkey | Medipol University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Medipol University |
Turkey,
Harding C, Frank L, Dungu C, Colton N. The use of nonnutritive sucking to facilitate oral feeding in a term infant: a single case study. J Pediatr Nurs. 2012 Dec;27(6):700-6. doi: 10.1016/j.pedn.2012.01.006. Epub 2012 Feb 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early Feeding Skills Assessment Tool | are the scores obtained by the clinician from the early feeding assessment tool. The minimum score that can be obtained from the scale is 19, and the maximum score is 57. A higher score indicates better feeding skills. | 1 month | |
Primary | Time from tube feeding to oral intake | how many days the baby transitions from tube feeding to oral intake | 20 days | |
Secondary | discharge time | how many days the baby is discharged from the neonatal intensive care unit | 1 month | |
Secondary | weight gain | is the weight information of the baby at certain intervals | 1 month |
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